SEVIKAR Film-coated tablet Ref.[51026] Active ingredients: Amlodipine Olmesartan medoxomil Olmesartan medoxomil and Amlodipine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Daiichi Sankyo UK Ltd., 1<sup>st</sup> Floor, Building 4, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH

Product name and form

Sevikar 20 mg/5 mg film-coated tablets.

Sevikar 40 mg/5 mg film-coated tablets.

Sevikar 40 mg/10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Sevikar 20 mg/5 mg film-coated tablets: White, round, film-coated tablet of 6 mm with C73 debossed on one side.

Sevikar 40 mg/5 mg film-coated tablets: Cream, round, film-coated tablet of 8 mm with C75 debossed on one side.

Sevikar 40 mg/10 mg film-coated tablets: Brownish-red, round, film-coated tablet of 8 mm with C77 debossed on one side.

Qualitative and quantitative composition

Sevikar 20 mg/5 mg film-coated tablets: Each film-coated tablet of Sevikar contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).

Sevikar 40 mg/5 mg film-coated tablets: Each film-coated tablet of Sevikar contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).

Sevikar 40 mg/10 mg film-coated tablets: Each film-coated tablet of Sevikar contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besilate).

Excipients with known effect: For the full list of excipients, see section 6.1.

Active Ingredient Description
Amlodipine

Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.

Olmesartan medoxomil

Olmesartan medoxomil is a potent, orally active, selective angiotensin II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin II. The selective antagonism of the angiotensin II (AT1) receptors results in increases in plasma renin levels and angiotensin I and II concentrations, and some decrease in plasma aldosterone concentrations.

Olmesartan medoxomil and Amlodipine

Combination of an angiotensin II receptor antagonist, olmesartan medoxomil, and a calcium channel blocker, amlodipine besilate. The combination of these active ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.

List of Excipients

Tablet core:

Starch, pregelatinised maize
Silicified microcrystalline cellulose (microcrystalline cellulose with colloidal silicon dioxide)
Croscarmellose sodium
Magnesium stearate

Tablet coat:

Polyvinyl alcohol
Macrogol 3350
Talc
Titanium dioxide (E171)
Iron (III) oxide yellow (E172) (Sevikar 40 mg/ 5 mg and 40 mg/10 mg film-coated tablets only)
Iron (III) oxide red (E172) (Sevikar 40 mg/ 10 mg film-coated tablets only)

Pack sizes and marketing

OPA / Aluminium / PVC / Aluminium blister.

Pack sizes: 14, 28, 30, 56, 90, 98, 10 × 28 and 10 × 30 film-coated tablets.

Pack sizes with perforated unit dose blisters: 10, 50 and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Daiichi Sankyo UK Ltd., 1st Floor, Building 4, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH

Marketing authorization dates and numbers

Sevikar 20 mg/5 mg film-coated tablet: PL 08265/0026
Sevikar 40 mg/5 mg film-coated tablet: PL 08265/0027
Sevikar 40 mg/10 mg film-coated tablet: PL 08265/0028

29 October 2008/12 July 2013

Drugs

Drug Countries
SEVIKAR Austria, Australia, Germany, Spain, Finland, France, Ireland, Italy, Netherlands, Romania, Tunisia, Turkey, United Kingdom

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